Table 1.

Exclusion rates by subgroup, stratified by study eraa

VariableContemporary Era (2006–2014), No. (%)Prior Era (1985–2005b), No. (%)P Value
TrialsExplicit Exclusion of KD, TrialsTrialsExplicit Exclusion of KD, Trials
Overall305 (100)139 (46)153 (100)86 (56)0.04
Trial enrollment no. of patients
 100–499114 (37)56 (49)40 (26)15 (38)0.20
 500–99965 (21)29 (45)23 (15)14 (61)0.23
 ≥1000126 (41)55 (44)90 (59)57 (63)<0.01
Sites
 Single center25 (8)13 (52)15 (10)3 (20)0.06
 Multicenter280 (92)126 (45)138 (90)83 (60)0.01
Locationc
 United States/Canada32 (10)13 (41)64 (42)48 (75)<0.01
 Europe123 (40)55 (45)77 (50)28 (36)0.76
 Asia/Australia/other21 (7)8 (38)12 (8)10 (83)0.03
Therapeutic class
 Thrombolytic3 (1)1 (33)27 (18)9 (33)>0.99
 PCI89 (29)26 (29)31 (20)11 (35)0.51
 Device (AICD/pacer)25 (8)4 (16)7 (5)3 (43)0.16
 RAAS inhibitor12 (4)10 (83)31 (20)29 (94)0.31
β blocker3 (1)0 (0)13 (8)7 (54)0.21
 Antiplatelet agent46 (15)24 (52)14 (9)5 (36)0.37
 Anticoagulants31 (10)23 (74)12 (8)11 (92)0.41
 Statins8 (3)5 (63)7 (5)5 (71)>0.99
 Non-RAAS modulation293 (96)129 (44)122 (80)57 (47)0.67
Funding source
 Industry168 (55)86 (51)87 (57)54 (62)0.11
 Government (NIH/VA)27 (9)11 (41)31 (20)14 (45)0.80
 Combination58 (19)22 (38)17 (11)11 (65)0.06
 Not specified25 (8)13 (52)18 (12)7 (39)0.54
Journal
 NEJM60 (20)30 (50)59 (39)38 (64)0.14
 JAMA39 (13)17 (44)12 (8)6 (50)0.75
 Lancet34 (11)10 (29)48 (31)23 (48)0.11
 Circulation33 (11)15 (46)12 (8)10 (83)0.04
 JACC57 (19)23 (40)11 (7)2 (18)0.19
 Am. Heart Journal17 (6)4 (24)6 (4)6 (100)<0.01
 Euro. Heart Journal37 (12)24 (65)5 (3)1 (20)0.14
 Annals of IM2 (1)1 (50)00>0.99
Diagnostic category
 AMI/ACS208 (68)92 (44)117 (76)58 (50)0.36
 CHF57 (19)29 (51)36 (24)28 (78)0.02
  • P values represent comparisons across groups. P value calculated using number of trials excluding KD not total trials. PCI, percutaneous coronary intervention; AICD, automated implantable cardioverter-defibrillator; NIH/VA, National Institute of Health/Veterans Affairs; NEJM, New England Journal of Medicine; JAMA, Journal of the American Medical Association; Am. Heart Journal, American Heart Journal; Euro. Heart Journal, European Heart Journal; Annals of IM, Annals of Internal Medicine; AMI, acute myocardial infarction; ACS, acute coronary syndromes; CHF, congestive heart failure.

  • a Only comparable data were included.

  • b Data from the 1985–2005 era were adopted from the study by Coca et al.5

  • c United States/Canada versus Europe used in chi-squared analysis.